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ORDER CREON® MINIMICROSPHERES® 

AND KNOW PRECISELY WHAT YOU’RE GETTING 

• Pancreatic enzymes have not been shown to be therapeutically equivalent and are not 

recommended for substitution 1 

• No AB-rated generic enzymes are available for CREON® MINIMICROSPHERES® 1 NDC 

The patented process of CREON®MINIMICROSPHERES® helps ensure 

precision delivery of optimal lipase levels with every dose. 2 

• Demonstrated symptom relief 3,4 

• Confident enzyme delivery 4 

• Optimally sized MINIMICROSPHERES® 4,5 

• Well tolerated 4,6 

Make sure your patients get the full range of benefits from the 

demonstrated performance of CREON® MINIMICROSPHERES®. 3,4 

CREON®MINIMICROSPHERES® is the # 1-prescribed pancreatic enzyme 

product in the US. 7 

Easy to Order 

Simply enter the line items that apply to your order; include product description, 

package size, and NDC: 

Product 

Package Size 

CREON® MINIMICROSPHERES® 5 CAPSULES 

100 

00032 

1205 

01 


250 

00032 

1205 

07 


100 

00032 

1210 

01 


250 

00032 

1210 

07 


100 

00032 

1220 

01 


250 

00032 

1220 

07 

INDICATION: 

CREON® MINIMICROSPHERES® capsules are indicated for patients with pancreatic exocrine 

insufficiency as is often associated with cystic fibrosis, chronic pancreatitis, postpancreatectomy, 

post-gastrointestinal bypass surgery, and ductal obstruction from neoplasm. 

SELECTED SAFETY INFORMATION: 

The most frequently reported adverse reactions to pancreatic enzyme-containing products 

are gastrointestinal in nature, which may include nausea, vomiting, bloating, cramping, 

constipation, or diarrhea. Less frequently, allergic-type reactions have also been observed. Very 

high doses of pancreatin have been associated with hyperuricosuria and hyperuricemia. 

REFERENCES: 1. Food and Drug Administration, HHS. Exocrine pancreatic 

insufficiency drug products; draft guidance for submitting new drug 

applications; notices. Fed Regist. 2004;69:23410-23414. 2. Boedecker B, 

Henninges F, Koelln K-J, et al, inventors; Kali-Chemie Pharma GmbH, assignee. 

Pancreatin micropellets prepared with polyethylene glycol 4000, paraffin and 

a lower alcohol by extrusion and rounding. US patent 5 378 462. January 3, 

1995. 3. Stern RC, Eisenberg JD, Wagener JS, et al. A comparison of the efficacy 

and tolerance of pancrelipase and placebo in the treatment of steatorrhea in 

cystic fibrosis patients with clinical exocrine pancreatic insufficiency. Am J 

Gastroenterol. 2000;95:1932-1938. 4. Data on file, Solvay Pharmaceuticals, 

Inc, Marietta, Ga. 5. Meyer JH, Elashoff J, Porter-Fink V, Dressman J, Amidon GL. 

Human postprandial gastric emptying of 1–3-millimeter spheres. 

Gastroenterology. 1988;94:1315-1325. 6. Whitehead AM. Study to compare 

the enzyme activity, acid resistance and dissolution characteristics of currently 

available pancreatic enzyme preparations. Pharm Weekbl Sci. 1988;10:12-16. 

7. IMS US Retail Data, December 2003–November 2004. 

Please see full prescribing information on back. 

THE #1 PRESCRIBED PANCREATIC ENZYME IN THE US 7 

PATENTED PRECISION 

© 2005 Solvay Pharmaceuticals, Inc. All rights reserved. 

Printed in USA CRN00139 150K January 2005

CREON ® 5 

MINIMICROSPHERES ® (Pancrelipase Delayed-release Capsules, USP) 

500197 Rev Nov 2004 

PRESCRIBING INFORMATION 

DESCRIPTION 

CREON ® 5 Capsules are orally administered and contain 124 mg of delayedrelease 

MINIMICROSPHERES ® of pancrelipase, which is of porcine 

pancreatic origin. Each CREON ® 5 Capsule contains lipase 5,000 USP Units, 

protease 18,750 USP Units and amylase 16,600 USP Units. 

Inactive ingredients include dibutyl phthalate, dimethicone, 

hydroxypropylmethylcellulose phthalate, light mineral oil and polyethylene 

glycol. The capsule shells contain gelatin, red iron oxide, titanium dioxide, 

yellow iron oxide and FD & C blue No. 2. The capsule imprinting ink 

contains dimethicone, 2-ethoxyethanol, shellac, soya lecithin, and titanium 

dioxide. 

CLINICAL PHARMACOLOGY 

The pancreatic enzymes in CREON ® 5 Capsules are enteric-coated to resist 

gastric destruction or inactivation. The pancreatic enzymes catalyze the 

hydrolysis of fats to glycerol and fatty acids, protein into proteoses and 

derived substances and starch into dextrins and short chain sugars. 

INDICATIONS 

CREON ® 5 Capsules are indicated for patients with pancreatic exocrine 

insufficiency as is often associated with: 

— cystic fibrosis 

— chronic pancreatitis 

— post-pancreatectomy 

— post-gastrointestinal bypass surgery (e.g., Billroth II gastroenterostomy) 

— ductal obstruction from neoplasm (e.g., of the pancreas or common bile 

duct) 

CONTRAINDICATIONS 

CREON ® 5 Capsules are contraindicated in the early stages of acute 

pancreatitis or in patients who are known to be hypersensitive to pork 

protein. 

WARNINGS 

Should symptoms of hypersensitivity appear, discontinue medication and 

initiate symptomatic and supportive therapy if necessary. 

Strictures in the ileo-cecal region and/or ascending colon have been reported 

in cystic fibrosis patients treated with high doses of high-potency pancreatic 

enzyme supplements containing 20,000 or greater USP units of lipase per 

capsule. The underlying mechanism is unknown, but caution should be 

exercised when doses in excess of 6,000 USP units lipase per kg per meal 

fail to resolve symptoms, especially in patients with a history of intestinal 

complications such as meconium ileus equivalent, short bowel syndrome, 

surgery or Crohn's disease. If symptoms suggestive of gastrointestinal 

obstruction occur, the possibility of bowel stricture should be investigated 

including evaluation of pancreatic enzyme therapy. 

PRECAUTIONS 

CREON ® 5 Capsules MINIMICROSPHERES ® SHOULD NOT BE CRUSHED OR 

CHEWED or placed on foods having a pH greater than 5.5. These can 

dissolve the protective enteric coating resulting in early release of enzymes, 

irritation of oral mucosa, and/or loss of enzyme activity. 

Information for Patients 

CREON ® 5 Capsules are a pancreatic enzyme product prescribed to promote 

improved digestion of foods, especially fat. The prescribed dosage should 

be taken with each meal and snack or as directed by the physician. The 

capsules can be swallowed whole, or the contents poured on soft, bland 

food. Care should be taken to avoid chewing or crushing of the capsule 

contents, which can result in early release of enzymes, irritation of oral 

mucosa, and/or loss of enzyme activity. Patients should maintain adequate 

fluid intake. The prescribed dose range should not be exceeded without 

calling your doctor. 

The most common adverse reactions involve the stomach and intestine 

including diarrhea, nausea, vomiting, bloating, constipation, stomach cramps 

or pain. If these symptoms are persistent, contact your doctor. 

Carcinogenesis, Mutagenesis, Impairment of Fertility 

Long-term studies in animals have not been performed to evaluate 

carcinogenic potential. 

Pregnancy, Category C 

Animal reproduction studies have not been conducted with pancrelipase. 

It is also not known whether pancrelipase can cause fetal harm when 

administered to a pregnant woman or can affect reproduction capacity. 

CREON ® 5 Capsules should be given to a pregnant woman only if clearly 

needed. 

Nursing Mothers 

It is not known whether this drug is excreted in human milk. Because many 

drugs are excreted in human milk, caution should be exercised when 

CREON ® 5 Capsules are administered to a nursing mother. 

ADVERSE REACTIONS 

The most frequently reported adverse reactions to pancreatic enzymecontaining 

products are gastrointestinal in nature which may include nausea, 

vomiting, bloating, cramping, constipation or diarrhea. Less frequently, 

allergic-type reactions have also been observed. Very high doses of 

pancreatin have been associated with hyperuricosuria and hyperuricemia. 

DOSAGE AND ADMINISTRATION 

Clinical experience should dictate initial starting dose. Doses should be 

taken during meals or snacks, not before or after. Do not take without food. 

Adults and Children Over 6 Years Old 

Usual initial starting dosage is two to four CREON ® 5 Capsules per meal or 

snack. 

Children Under 6 Years Old 

The exact dosage of CREON ® 5 Capsules should be selected based on clinical 

experience for this age group. Patients can be started on one to two 

capsules per meal or snack. 

For cystic fibrosis patients, typical doses are 1,500 - 3,000 USP lipase 

units/kg/meal. Dosage should be adjusted according to the severity of the 

disease, control of steatorrhea and maintenance of good nutritional status. 

Doses in excess of 6,000 USP lipase units/kg/meal are not recommended. 

Dose increases, if required, should occur with careful monitoring of body 

weight and stool fat content. When changing strengths of pancreatic enzyme 

products, care should be taken to maintain equivalent lipase units for each 

divided dosage. 

It is important to ensure adequate hydration of patients at all times while 

taking pancreatic enzymes. 

Where swallowing of capsules is difficult, the capsules may be carefully 

opened and the MINIMICROSPHERES ® added to a small amount of soft 

food, with a pH less than 5.5. The soft food should be swallowed 

immediately without chewing and followed with a glass of water or juice to 

insure swallowing. 

HOW SUPPLIED 

CREON ® 5 MINIMICROSPHERES ® (Pancrelipase Delayed-release Capsules, 

USP) are available in a two-piece gelatin capsule (orange opaque top half, 

blue opaque bottom half) imprinted in white with "SOLVAY" and "1205". Each 

capsule contains tan-colored delayed-release MINIMICROSPHERES ® of 

pancrelipase supplied in bottles of: 

100....... NDC 0032-1205-01 

250....... NDC 0032-1205-07 

CREON ® 5 Capsules must be stored at 25ºC (77ºF); excursions permitted to 

15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.] PROTECT 

FROM MOISTURE. DO NOT REFRIGERATE. Dispense in tight, light-resistant 

containers. For human consumption only. 

Manufactured By: 

Solvay Pharmaceuticals GmbH, 

Hannover, Germany 

Marketed by: 

Solvay Pharmaceuticals, Inc. 

Marietta, GA 30062 

500197 Rev Nov 2004 

© 2004 Solvay Pharmaceuticals, Inc. 

CREON ® 10 


500198 Rev Nov 2004 


DESCRIPTION 


MINIMICROSPHERES ® of pancrelipase, which is of porcine 

pancreatic origin. Each CREON ® 10 Capsule contains lipase 10,000 USP 

Units, protease 37,500 USP Units and amylase 33,200 USP Units. 



glycol. The capsule shells contain black iron oxide, gelatin, red iron oxide, 

titanium dioxide, and yellow iron oxide. The capsule imprinting ink contains 

dimethicone, 2-ethoxyethanol, shellac, soya lecithin, and titanium dioxide. 




hydrolysis of fats to glycerol and fatty acids, protein into proteoses and 

derived substances and starch into dextrins and short chain sugars. 

INDICATIONS 




— chronic pancreatitis 

— post-pancreatectomy 

— post-gastrointestinal bypass surgery (e.g., Billroth II gastroenterostomy) 

— ductal obstruction from neoplasm (e.g., of the pancreas or common bile 

duct) 




protein. 

WARNINGS 










surgery or Crohn's disease. If symptoms suggestive of 

gastrointestinal obstruction occur, the possibility of bowel stricture should be 

investigated including evaluation of pancreatic enzyme therapy. 

PRECAUTIONS 


























needed. 







products are gastrointestinal in nature which may include 

nausea, vomiting, bloating, cramping, constipation or diarrhea. Less 

frequently, allergic-type reactions have also been observed. Very high 

doses of pancreatin have been associated with hyperuricosuria and 

hyperuricemia. 





Usual initial starting dosage is one to two CREON ® 10 Capsules per meal or 

snack. 


Usual initial starting dosage is up to one CREON ® 10 Capsule per meal or 

snack. 


units/kg/meal. 

Dosage should be adjusted according to the severity of the disease, control 

of steatorrhea and maintenance of good nutritional status. Doses in excess 

of 6,000 USP lipase units/kg/meal are not recommended. 












HOW SUPPLIED 


USP) are available in a two-piece gelatin capsule (brown opaque top half, 

natural transparent bottom half) imprinted in white with "SOLVAY" and 

"1210". Each capsule contains tan-colored delayed-release 

MINIMICROSPHERES ® of pancrelipase supplied in bottles of: 

100....... NDC 0032-1210-01 

250....... NDC 0032-1210-07 






Solvay Pharmaceuticals GmbH 


Marketed by: 



500198 Rev Nov 2004 

© 2004 Solvay Pharmaceuticals, Inc. 

CREON ® 20 


500199 Rev Nov 2004 


DESCRIPTION 


MINIMICROSPHERES ® of pancrelipase, which is of porcine pancreatic origin. 

Each CREON ® 20 Capsule contains lipase 20,000 USP Units, protease 75,000 

USP Units and amylase 66,400 USP Units. 



glycol. The capsule shells contain gelatin, red iron oxide, titanium dioxide 

and yellow iron oxide. The capsule imprinting ink contains dimethicone, 2- 

ethoxyethanol, shellac, soya lecithin, and titanium dioxide. 




hydrolysis of fats to glycerol and fatty acids, 

protein into proteoses and derived substances and starch into dextrins and 

short chain sugars. 

INDICATIONS 




— cychronic pancreatitis 

— cypost-pancreatectomy 

— cypost-gastrointestinal bypass surgery (e.g., Billroth II 

gastroenterostomy) 

— cyductal obstruction from neoplasm (e.g., of the pancreas or common 

bile duct) 




protein. 

WARNINGS 










surgery or Crohn’s disease. If symptoms suggestive of gastrointestinal 

obstruction occur, the possibility of bowel stricture should be investigated 

including evaluation of pancreatic enzyme therapy. 

PRECAUTIONS 


























needed. 







products are gastrointestinal in nature which may include nausea, 

vomiting, bloating, cramping, constipation or diarrhea. Less frequently, 

allergic-type reactions have also been observed. Very high doses of 

pancreatin have been associated with hyperuricosuria and hyperuricemia. 





Usual initial starting dosage is one CREON ® 20 Capsule per meal or snack. 


The exact dosage of CREON ® 20 Capsules should be selected based on 

clinical experience for this age group. 


units/kg/meal. Dosage should be adjusted according to the severity of the 

disease, control of steatorrhea and maintenance of good nutritional status. 

Doses in excess of 6,000 USP lipase units/kg/meal are not recommended. 












HOW SUPPLIED 


USP) are available in a two-piece gelatin capsule (orange opaque top half, 

natural transparent bottom half) imprinted in white with “SOLVAY” and 

“1220”. Each capsule contains tan-colored delayed-release 

MINIMICROSPHERES ® of pancrelipase supplied in bottles of: 

100....... NDC 0032-1220-01 

250....... NDC 0032-1220-07 






Solvay Pharmaceuticals GmbH, 


Marketed by: 


only only only 


500199 Rev Nov 2004 

© 2004 Solvay Pharmaceuticals, Inc.

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